Senior Manager, Quality Assurance

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Acadia Pharmaceuticals Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1993

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

💰 $287.5M Post-IPO Equity on 2019-09

Healthcare • Pharmaceuticals • Biotechnology

Acadia Pharmaceuticals Inc. is a pharmaceutical company specializing in breakthroughs in neuroscience to enhance lives. For over 30 years, Acadia has been at the forefront of healthcare, pioneering treatments for conditions like Parkinson’s disease psychosis and Rett syndrome. The company's focus is on developing innovative and novel medicines that address unmet medical needs, especially in therapeutic areas with high demand, such as Prader-Willi syndrome, Alzheimer’s disease psychosis, and other central nervous system disorders. Acadia is dedicated to elevating life by embracing diverse perspectives, fostering collaboration, and advancing scientific research and development.

📋 Description

• Lead and support core QMS processes, including Management Review and Annual Product Quality Reviews (APQRs). • Review batch documentation and support commercial product release activities, including deviation management, CAPA implementation, and change control. • Plan, conduct, and follow up on internal audits, supplier audits, and regulatory inspections. • Drive continuous improvement initiatives and support quality risk management. • Manage supplier oversight activities, including qualification, performance monitoring, and revisions of quality agreements. • Support GDP compliance programs, including transportation and distribution oversight, warehousing activities, temperature excursion management, customer qualification, and recall readiness. • Ensure compliance with data integrity requirements and governance of computerized systems, electronic records, and electronic signatures. • Collaborate with Regulatory Affairs, Manufacturing, Supply Chain, Distribution, and other cross-functional teams to support compliant product release and distribution activities. • Identify, assess, and escalate quality and compliance risks as appropriate.

🎯 Requirements

• Bachelor’s degree in a Health Science discipline required; Master’s degree preferred. Equivalent combinations of education and relevant experience will be considered. • Minimum 5 years of experience within the pharmaceutical manufacturing industry with focus on quality assurance. • Strong knowledge of EU GMP (EudraLex Volume 4), EU GDP Guidelines (2013/C 343/01), Directive 2001/83/EC, ICH Q7, Q9, and Q10, and other relevant regulatory requirements. • Proven experience managing outsourced GMDP activities. • Hands-on experience with electronic quality management systems such as Veeva Vault, TrackWise, or equivalent platforms. • Strong organizational and project management skills with the ability to manage multiple priorities simultaneously. • Excellent attention to detail and commitment to quality. • Effective negotiation and stakeholder management skills. • Ability to independently assess complex situations, resolve issues, and recommend practical solutions. • Strong risk-based decision-making and problem-solving capabilities. • Excellent written and verbal communication skills with the ability to convey complex information to diverse audiences. • Demonstrated ability to build collaborative relationships and work effectively across functions and external partners.

🏖️ Benefits

• Competitive base, bonus, new hire and ongoing equity packages • Medical, dental, and vision insurance • Employer-paid life, disability, business travel and EAP coverage • 401(k) Plan with a fully vested company match 1:1 up to 5% • Employee Stock Purchase Plan with a 2-year purchase price lock-in • 15+ vacation days • 13 -15 paid holidays, including office closure between December 24th and January 1st • 10 days of paid sick time • Paid parental leave benefit • Tuition assistance